Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 807-560-2 | CAS number: 123944-63-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
SKIN IRRITATION/CORROSION
Non-corrosive; in vitro; Corrositex® test method
Not irritating; rabbit; Code of Federal Regulations, Title 16, Section 1500, 41
EYE IRRITATION
Not irritating; rabbit; Code of Federal Regulations, Title 16, Section 1500, 42
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation
- Remarks:
- in vitro
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The information is provided from a reliable secondary source.
- Qualifier:
- according to guideline
- Guideline:
- other: Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 42
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- - the original study was conducted in 1975
- Species:
- rabbit
- Strain:
- other: Albino
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- No data
- Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Ocular reactions were scored using the Draize method. Eyes were evaluated at 24, 48 and 72 hours and animals continued to be observed for the remainder of the 7 days.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0.05
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Redness of the conjunctiva was observed in 3 animals, which persisted up to 7 days in 2 animals. Chemosis was seen in 1 animal, which resolved by 48 hours.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material is non-irritating to the eye.
- Executive summary:
The eye irritation potential of the test material was investigated in accordance with the standard methods prescribed by the Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 42. These methods are similar to those outlined in the standardised guideline OECD 405.
Six Albino rabbits were exposed to the test material and observed for 7 days. Ocular reactions were scored using the Draize method. Eyes were evaluated at 24, 48 and 72 hours and animals continued to be observed for the remainder of the 7 days.
Redness of the conjunctiva was observed in 3 animals, which persisted up to 7 days in 2 animals. Chemosis was seen in 1 animal, which resolved by 48 hours.
Under the conditions of this study, the test material is non-irritating to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation/Corrosion
This endpoint is addressed on a weight of evidence basis using an in vitro corrosion test and an in vivo irritation test conducted on a read across substance.
The test material was analysed by the in vitro Corrositex method to determine its corrosive potential and Packing Group designation.
The Corrositex test is a standardised and reproducible method that can be employed to determine the potential corrosivity and determine the Packing Group classification of specified categories of chemical compounds under the hazardous materials transportation regulations administered by the U.S. Department of Transportation (DOT) and international dangerous goods codes. The Corrositex test predicts the in vivo corrosive potential of a chemical compound or mixture by using as an endpoint the time it takes for the chemical to permeate through or destroy a synthetic biobarrier. When the chemical has passed through this biobarrier, a visual change is produced in a proprietary Chemical Detection System (CDS).
The Corrositex test is performed in three steps. First, a qualification test is done to ensure that the test material and the CDS reagent are compatible. The second step utilises appropriate indicator solutions to permit categorisation of the test material as either a Category 1 or Category 2 material. The third step is performed by applying the test sample to the biobarrier. When the chemical permeates through or destroys the full thickness of this biobarrier, it comes into contact with the CDS which then undergoes a simple colour change. This colour change is visually observed and the time required for the colour change to occur is recorded. The time required to destroy the biobarrier is recorded for four sample replicates and the mean of these replicates is utilised to designate the UN Packing Group classification.
The results indicated that the test material was compatible with the Corrositex system and was classified as Category 2 material. The results obtained from the evaluation of four replicate samples were highly reproducible. The test material demonstrated a mean time of >60 minutes required to destroy the synthetic biobarriers.
Under the conditions of this study, the test material was found to be non-corrosive.
The skin irritation potential of Sanolin Blue EHRLwas investigated in accordance with the standard methods prescribed by the Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 41.
The test material in distilled water was applied to the intact and abraded skin of Albino rabbits and the skin irritation assessed using a patch test technique that was carried out in an occlusive fashion. Animals were observed for 72 hours.
Evaluation of skin reactions (scores) was not provided. The summary report states that no animals showed any observable response to treatment throughout the 72 hour observation period.
Under the conditions of this study, the test material is non-irritating to skin.
Eye Irritation
The eye irritation potential of Sanolin Blue EHRL was investigated in accordance with the standard methods prescribed by the Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 42. Six Albino rabbits were exposed to the test material and observed for 7 days. Ocular reactions were scored using the Draize method. Eyes were evaluated at 24, 48 and 72 hours and animals continued to be observed for the remainder of the 7 days. Redness of the conjunctiva was observed in 3 animals, which persisted up to 7 days in 2 animals. Chemosis was seen in 1 animal, which resolved by 48 hours.
Under the conditions of this study, the test material is non-irritating to the eye.
Justification for selection of skin irritation / corrosion endpoint:
This endpoint is addressed on a weight of evidence basis. Therefore no single study is selected as key.
Justification for selection of eye irritation endpoint:
Only one study available.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to either skin or eye irritation.
In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance does not require classification with respect to either skin or eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.